What the label lists and what reports show
Encorafenib side effects
Encorafenib's FDA label: “Most common adverse reactions (≥25%) for BRAFTOVI, in combination with binimetinib, are fatigue, nausea, vomiting, abdominal pain, and arthralgia.” FAERS holds 9,844 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (842 reports).
- No generic listed
Check it at the source: the encorafenib FDA label on DailyMed (effective February 26, 2026, Array BioPharma Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of BRAFTOVI?BRAFTOVI can cause serious side effects, including: • See " What is the most important information I should know about BRAFTOVI? " • Heart problems, including heart failure. BRAFTOVI can cause heart problems. Your healthcare provider will check your heart function before and during treatment with BRAFTOVI. Tell your healthcare provider right away if you get any of the following signs and symptoms of a heart problem: o feeling like your heart is pounding or racing o shortness of breath o swelling in your hands, ankles legs or feet o feeling faint or lightheaded • Liver problems. BRAFTOVI can cause liver problems. Your healthcare provider will perform blood tests to check your liver function before and during treatment with BRAFTOVI. […]
Source: FDA drug label, Array BioPharma Inc., effective February 26, 2026 (SPL set 235dfc38-0f0b-4037-b501-7a9f4294740c), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥25%) for BRAFTOVI, in combination with binimetinib, are fatigue, nausea, vomiting, abdominal pain, and arthralgia.
Table 7: Adverse Reactions Occurring in ≥10% of Patients Receiving BRAFTOVI in Combination with Cetuximab and mFOLFOX6 in BREAKWATER Grades per National Cancer Institute CTCAE v4.03.
| Reaction | All Grades (%) | Grade 3 or 4 (%) | All Grades (%) | Grade 3 or 4 (%) | All Grades (%) | Grade 3 or 4 (%) |
|---|---|---|---|---|---|---|
| Peripheral neuropathy Represents multiple related terms. | 64 | 19 | 53 | 9 | 57 | 10 |
| Headache | 15 | 0.4 | 9 | 0 | 12 | 0 |
| Dysgeusia | 15 | 0 | 14 | 0 | 19 | 0 |
| Neurotoxicity | 11 | 6 | 8 | 0 | 12 | 0 |
| Nausea | 54 | 3 | 50 | 3.9 | 44 | 2.6 |
| Diarrhea | 42 | 1.3 | 50 | 4.8 | 44 | 2.6 |
| Vomiting | 36 | 3.9 | 22 | 2.2 | 17 | 1.7 |
| Abdominal pain | 32 | 5 | 31 | 1.7 | 30 | 1.7 |
| Constipation | 27 | 0.4 | 23 | 0.4 | 25 | 0.9 |
| Stomatitis | 17 | 2.2 | 16 | 1.3 | 19 | 1.7 |
| Fatigue | 53 | 7 | 41 | 4.8 | 45 | 7 |
| Pyrexia | 29 | 2.2 | 16 | 0.4 | 17 | 0.9 |
| Decreased appetite | 38 | 2.2 | 27 | 1.3 | 30 | 2.6 |
| Rash | 36 | 1.3 | 6 | 0 | 5 | 0 |
| Alopecia | 23 | 0 | 11 | 0 | 12 | 0 |
| Dry skin | 22 | 0.4 | 6 | 0 | 5 | 0 |
| Dermatitis acneiform | 20 | 0.9 | 1.3 | 0 | 0.9 | 0 |
| Skin hyperpigmentation | 19 | 0 | 3.1 | 0 | 1.7 | 0 |
| Pruritus | 14 | 0 | 3.9 | 0.4 | 5 | 0.9 |
| Hemorrhage | 34 | 2.6 | 21 | 1.3 | 15 | 1.7 |
| Edema | 11 | 0 | 4.4 | 0 | 6 | 0 |
| Arthralgia | 32 | 2.6 | 6 | 0.4 | 7 | 0.9 |
| Myopathy | 19 | 0 | 4.8 | 0.4 | 6 | 0.9 |
| Musculoskeletal pain | 14 | 0.9 | 10 | 1.3 | 13 | 1.7 |
| COVID-19 | 16 | 0.9 | 17 | 0.4 | 16 | 0.9 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are described elsewhere in the labeling: • New Primary Malignancies [see Warnings and Precautions (5.1) ] • Tumor Promotion in BRAF Wild-Type Tumors [see Warnings and Precautions (5.2) ] • Cardiomyopathy [see Warnings and Precautions (5.3) ] • Hepatotoxicity [see Warnings and Precautions (5.4) ] • Hemorrhage [see Warnings and Precautions (5.5) ] • Uveitis [see Warnings and Precautions (5.6) ] • QT Prolongation [see Warnings and Precautions (5.7) ] • Embryo-Fetal Toxicity [see Warnings and Precautions (5.8) ] • Risks Associated with BRAFTOVI as a Single Agent [see Warnings and Precautions (5.9) ] • Risks Associated with Combination Treatment [see Warnings and Precautions (5.10) ] • Melanoma: Most common adverse reactions (≥25%) for BRAFTOVI, in combination with binimetinib, are fatigue, nausea, vomiting, abdominal pain, and arthralgia. ( 6.1 ) • CRC : Most common adverse reactions (≥25%) for BRAFTOVI, in combination with cetuximab and mFOLFOX6, are peripheral neuropathy, nausea, fatigue, diarrhea, decreased appetite, rash, vomiting, hemorrhage, abdominal pain, arthralgia, pyrexia, and constipation. ( 6.1 ) • Most common adverse reactions (≥25%) for BRAFTOVI, in combination with cetuximab and FOLFIRI are nausea, diarrhea, fatigue, vomiting, alopecia, constipation, abdominal pain, decreased appetite, and rash. …
Source: FDA drug label, Array BioPharma Inc., effective February 26, 2026 (SPL set 235dfc38-0f0b-4037-b501-7a9f4294740c), via openFDA; the full label on DailyMed
What do FAERS reports show?
9,844 reports list encorafenib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,627 are coded as a death and 2,733 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 14 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Encorafenib: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions